MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T

Model Number 989605455171

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The service engineer tested the system and was able to confirm the reported problem.A visual inspection revealed deposits inside the transducer connector which caused a poor connection between the system and the transducer.After carefully removing the deposits and cleaning the contacts of the connector, the system and transducer passed all tests and resumed normal operation.Both the system and transducer remain in use at the customer site with no return anticipated; therefore, no further failure analysis can be performed.

Event Description

A customer reported encountering an incident where their epiq ultrasound system would not recognize the x8-2t tee model transducer during an elective aortic valve replacement.The failure occurred while the transducer was inserted in the patient, but prior to the bypass surgery.After rebooting the system twice, the transducer became fully functional and the procedure was successfully completed with no adverse effect to the patient.

• Brand Name: TRANSDUCER X8-2T
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 9440524
• MDR Text Key: 176315336
• Report Number: 3019216-2019-00087
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605455171
• Device Lot Number: B2XDCJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1